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Completed

NCT Number: NCT00176384

Impact of Exercise Training on Exercise Capacity in Patients With Severe Chronic Heart Failure

Patients with heart failure are limited in their exercise capacity due to skeletal muscle alteration and an impairment of peripheral perfusion. Regular physical exercise training has been shown to partially correct these peripheral maladaptations in patients with stable heart failure, which was associated with an improvement in exercise capacity. However, it is unknown so far, whether regular physical activity also exerts beneficial effects in patients with severe chronic heart failure.

Aim of the trial is therefore to assess the effects of aerobic exercise training on exercise capacity, muscle maladaptations and peripheral perfusion in patients with severe chronic heart failure according to NYHA class III b.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

University of Leipzig, Heart Center, Department of Internal Medicine / Cardiology

Leipzig, Saxony, 04289, Germany

About this study

A total of 36 patients with severe chronic heart failure are prospectively randomized to either 3 months of aerobic ergometer training or a sedentary control group.

Before and after the intervention period maximal exercise capacity is assessed by ergospirometry, endothelial function is determined by high-resolution A-mode ultrasound, and muscle mass is determined by CT. Skeletal muscle biopsies are obtained at begin and after 3 months and are analyzed for markers of muscle catabolism/anabolism.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • chronic heart failure (NYHA class III b)
  • peak oxygen uptake <20 mL/min/kg body weight
  • left ventricular ejection fraction <25 %
  • left ventricular end-diastolic diameter >60 mm

Exclusion criteria

  • exercise-induced myocardial ischemia
  • cardiac decompensation within the last 8 weeks
  • ventricular arrhythmias (>Lown 4b) in patients not protected by an ICD
  • insulin-dependent diabetes mellitus
  • uncontrolled arterial hypertension
  • orthopedic conditions excluding training participation
  • body mass index >30 kg/m2

Treatment and study plan

Aerobic endurance exercise training (ergometer)

Behavioral

Primary outcomes

  1. Peak oxygen uptake

Secondary outcomes

  1. Endothelial function

  2. Skeletal muscle mass

  3. Markers of muscle anabolism / catabolism

Sponsors and collaborators

Lead sponsor

University of Leipzig

Other

Collaborators

  • Deutsche Stiftung für Herzforschung

Registry information

Official study title

Impact of Three Months of Aerobic Exercise Training on Exercise Capacity and Peripheral Maladaptations in Patients With Severe Chronic Heart Failure (NYHA III b)

Important dates

Study start
2003
Study completion
2006
First posted
Sep 15, 2005
Registry last updated
Aug 1, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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